Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that in patients with a drug-eluting coronary artery stent, discontinuing clopidogrel after six months didn't raise the composite risk of cardiac death, MI, and target vessel revascularization compared with a 12-month regimen in addition to aspirin.

Note that diabetics were identified as a higher-risk subgroup for which early discontinuation of clopidogrel may not be safe.

This met noninferiority criteria in the 1,443-patient randomized trial presented here at the American College of Cardiology meeting.

Although underpowered for "hard" clinical endpoints, the study didn't show any signals for risk either.

"At least in low risk patients -- nondiabetics treated with drug-eluting stents -- maybe we can safely discontinue clopidogrel at six months, particularly for patients at high risk of bleeding or anticipating some surgery," Gwon said at a press conference where the results were discussed.

Current guidelines recommend at least 12 months of dual-antiplatelet therapy to prevent venous thromboembolism after getting a drug-eluting stent, but that's based on relatively weak observational studies.

But the bleeding risk with antiplatelet therapy raises concern about undergoing other procedures, which may be delayed until the drugs can be safely stopped, Gwon noted.

"Frequently we're confronted by patients on Plavix and aspirin, and we may have to put a pacemaker or defibrillator in them," noted Byron Lee, MD, of the University of California San Fransisco and co-chair of the meeting.

"Knowing that this study showed noninferiority, I feel much more comfortable now taking them off Plavix if it's been past six months," he told MedPage Today at the press conference, which he moderated.

However, there were higher-risk subgroups for which early discontinuation may not be safe, Gwon and Lee agreed.

The study showed significantly higher risk of the primary target vessel failure composite endpoint with early discontinuation of clopidogrel for patients with diabetes (P=0.006) and a trend in younger patients (P=0.115).

Gwon noted that there were crossovers who continued on clopidogrel past their randomized assignment to six-months' duration (26.6%). Some of those cases were because patients who had a major adverse cardiac or cerebrovascular event and remained on the drug for secondary prevention, but most were because patients or physicians felt unsafe, he said.

Per-protocol analysis excluding crossovers still showed noninferiority between the strategies.

And while the six-month strategy looked worse than 12 months of clopidogrel in the sirolimus-eluting stent group (5.0% versus 2.2% for target vessel failure, P=0.268 for noninferiority), this comparison may have been too small.

The researchers also cautioned that the incidence of the primary endpoint was lower than expected and that a significant proportion of patients crossed over to longer or shorter duration of clopidogrel in both groups.

Thus, a larger-scale randomized trial is needed to test the impact of a shorter duration of clopidogrel on the hard endpoints of death, MI, and stent thrombosis, Gwon concluded.

Gwon reported consulting fees or honoraria from Cordis and Medtronic Asia Pacific and research funding from Abbott Korea and Medtronic Korea.

Lee reported consulting fees or honoraria from Biotronik, St. Jude, and Nanostim and research funding from Medtronic and Zoll.

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